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      Higher Risk of Hospitalization and Serious Infection Among Patients With Ulcerative Colitis Treated with Adalimumab, Compared with Infliximab, in a Nationwide Study

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          Abstract

          Background & Aims

          We compared the effectiveness and safety of infliximab and adalimumab in biologic-naïve patients with ulcerative colitis (UC), in a nationwide register-based propensity score-matched study of patients in Denmark.

          Methods

          We collected data from 1719 adults with UC, 15–75 years old, in Denmark who were treated with either infliximab or adalimumab as their first biologic agent. We compared rates of all-cause hospitalization, UC-related hospitalization, major abdominal surgery, and serious infections after a variable 2:1 propensity score matching, accounting for baseline clinical characteristics, disease severity, healthcare use, and use of UC-related medications.

          Results

          Compared to patients treated with infliximab, patients treated with adalimumab had a higher risk for all-cause hospitalization (hazard ratio [HR], 1.84; 95% CI, 1.18–2.85), with a trend towards higher risk of UC-related hospitalization (HR, 1.71; 95% CI, 0.95–3.07)—particularly for patients on concomitant immune modulator therapy. However, risk of abdominal surgery (HR, 1.35; 95% CI, 0.62–2.94) did not differ between patients given adalimumab vs infliximab. Risk of serious infection requiring hospitalization was significantly higher among patients treated with adalimumab (HR, 5.11; 95% CI, 1.20–21.80).

          Conclusion

          In a nationwide propensity score matched-cohort study of biologic-naïve adults with UC in Denmark, use of adalimumab as first-line biologic vs infliximab was associated with higher risk of hospitalization and serious infections, though risk of surgery was not different. In the absence of trials to directly compare these drugs, these findings could assist patients, healthcare providers, purchasers, and policy makers in making decisions that might improve care for patients with UC.

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          Author and article information

          Contributors
          Role: Professor
          Journal
          101160775
          31839
          Clin Gastroenterol Hepatol
          Clin. Gastroenterol. Hepatol.
          Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
          1542-3565
          1542-7714
          21 December 2016
          29 November 2016
          August 2017
          01 August 2018
          : 15
          : 8
          : 1218-1225.e7
          Affiliations
          [1 ]Division of Gastroenterology, University of California San Diego, La Jolla, California, USA
          [2 ]Department of Epidemiology Research, Statens Serum Institute, Copenhagen, Denmark
          [3 ]Divison of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota
          [4 ]Institute of Preventive Medicine, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
          Author notes
          Corresponding author: Siddharth Singh, MD, MS, Assistant Professor of Medicine, Division of Gastroenterology, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, sis040@ 123456ucsd.edu , Phone: 858-657-5271, Fax: 858-657-7259
          Article
          PMC5447492 PMC5447492 5447492 nihpa832989
          10.1016/j.cgh.2016.11.024
          5447492
          27913244
          cc28489c-0a9d-4909-a062-15274c35d0c7
          History
          Categories
          Article

          biologics,inflammatory bowel disease,ropensity matching,Comparative effectiveness

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